78 FR 238 pgs. 75355-75356 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Type: NOTICEVolume: 78Number: 238Pages: 75355 - 75356
Pages: 75355, 75356FR document: [FR Doc. 2013-29510 Filed 12-10-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Health Resources and Services Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
AGENCY:
Health Resources and Services Administration, HHS.
ACTION:
Notice.
SUMMARY:
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
DATES:
Comments on this ICR should be received within 30 days of this notice.
ADDRESSES:
Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT:
To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Stem Cell Therapeutic Outcomes Database.
OMB #0915-0310-Revision.
[top] Abstract: The Stem Cell Therapeutic and Research Act of 2005, Public Law (Pub. L.) 109-129, as amended by the Stem Cell Therapeutic and Research Reauthorization Act of 2010, Public Law 111-264 (the Act), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. HRSA's Healthcare Systems Bureau has established the Stem Cell Therapeutic Outcomes Database. Operation of this database necessitates certain record
Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.
| Form name | Number of respondents | Responses per respondent | Total responses | Hours per response | Total burden hours |
|---|---|---|---|---|---|
| Baseline Pre-Transplant Essential Data (TED) | 200 | 38 | 7,600 | 1 | 7,600 |
| Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) | 200 | 29 | 5,800 | 1 | 5,800 |
| 100-Day Post-TED | 200 | 38 | 7,600 | 0.85 | 6,460 |
| 6-Month Post-TED | 200 | 31 | 6,200 | 1 | 6,200 |
| 12-Month Post-TED | 200 | 27 | 5,400 | 1 | 5,400 |
| Annual Post-TED | 200 | 104 | 20,800 | 1 | 20,800 |
| Total | 200 | 53,400 | 52,260 |
Dated: December 5, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-29510 Filed 12-10-13; 8:45 am]
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